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Completed

NCT Number: NCT00422929

Eustachian Tube Growth and Development

This study is to measure over time (from 3 years until 13 years of age) Eustachian tube function (the way the Eustachian tube works) and facial growth in groups of children with two types of middle-ear disease and with little past middle-ear disease. These measures will be used to determine if facial growth is related to improved Eustachian tube function, to see if the better function explains why young children who have middle-ear disease outgrow it as they get older, and to determine if these measures are different for the children in the three groups defined by disease history.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

3 year–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT Research Center, Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

About this study

The existing literature documents an important role for the Eustachian tube (ET) in the pathogenesis and/or persistence of otitis media (OM). Cross-sectional studies report a lower prevalence of OM in older children, a better ET pressure-regulating function in older children and age-related differences in ET form, length and width, and the vector orientation of the paratubal musculature. These growth-related changes in ET structural relationships are demonstrably predictive of increasingly more efficient ET function (ETF) and, because the ET and paratubal musculature are intimately related to the cranial base, the vector orientation of the ET system can be reconstructed from osteological or radiographic data. Together, these observations suggest that measurable, age-related changes in ET-paratubal muscle vector relationships are reflected in more efficient ETF and, by consequence, a decreased OM risk. The overall goal of the proposed longitudinal study is to evaluate the validity of this hypothesis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3 years of age
  • History of middle ear disease must fit into one of the 3 categories of ear history
  • With or without patent tympanostomy tubes at time of entry
  • Generally good health

Exclusion criteria

  • Cleft palate or other syndromes predisposing to otitis
  • History of significant orthodontic treatment or plan for such
  • Cholesteatoma or other past ear surgery other than tubes
  • Unable to cooperate for testing

Treatment and study plan

Primary outcomes

  1. change in Eustachian tube function

    Time frame: 5 years

    Eustachian tube function is tested yearly from age 3 years through age 7 years

Secondary outcomes

  1. change in craniofacial measures

    Time frame: 5 years

    cross-correlations of anthropometric variables obtained by facial measurements, with growth over 5 years

Other outcomes

  1. change in cephalometric variables

    Time frame: 5 years

    measurements obtained on cephalometric x-rays

  2. change in later Eustachian tube function

    Time frame: 11 years

    Eustachian tube function tested yearly through 13 years of age

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Eustachian Tube Growth and Development: Anatomy/Function

Important dates

Study start
2006
Primary completion
2017
Study completion
2018
First posted
Jan 17, 2007
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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